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Contestability of the efficacy assessment

Background

What is contestability?

Through the Efficiency through contestability programme, the Australian Government is assessing its functions to determine if performance can be improved through alternative structures, processes or provider arrangements. Contestability encourages Commonwealth entities to adopt a more commercial mindset and seek ways of improving the performance of existing or proposed government functions.

Contestability shifts the emphasis from the function to be carried out to the desired outcome government seeks to achieve.

Project information

What are we doing?

The APVMA is investigating if it is possible to move the function of conducting or commissioning a data assessment from the APVMA to the private sector while retaining the outcome—that the APVMA makes quality decisions about registration or variation applications.

Why are we doing it?

Contestability is a whole-of-government initiative aimed at moving towards a smaller, more nimble government. Contestability looks at using the private sector to deliver certain services at the same standard for a reduced cost.

Moving the function of conducting or commissioning data assessments from the APVMA to alternate private sector providers has the potential to:

provide applicants with more control regarding data assessment timeframes and costs

reduce administration processes within the APVMA

increase efficiency of application processing

open the area of data assessment to competition.

How are we doing it?

The APVMA is running a pilot to determine whether moving the function of conducting or commissioning a data assessment from the APVMA to the private sector:

is feasible

can increase efficiencies within the APVMA

can increase efficiencies for industry

will maintain the APVMA’s ability to make quality decisions regarding registration and variation applications.

The pilot aims to identify and rectify any potential issues and demonstrate whether the proposed process can increase the efficiency of application processing.

Only the efficacy and target crop/animal safety assessment will be considered in the pilot. The efficacy and target crop/animal safety assessment is considered less complicated for inclusion in the pilot because it does not require standard setting or publication of outcomes.

A list of efficacy reviewers selected to participate in the pilot is available on the APVMA website. Participating applicants can select a reviewer from this list to assess efficacy and target crop/animal safety data submitted for applications involved in the pilot.

Outline of pilot process

Key milestones

Full pilot details are now available and pilot applications may be submitted from July 2016.

The pilot efficacy reviewers are listed by the product type/s they can review for the pilot. The list will be updated during the course of the pilot if reviewers leave the pilot or new reviewers are added.

The APVMA’s expectations of the pilot efficacy reviewers is now available.

The APVMA’s expectations of the pilot applicants and what the pilot applicants can expect from the APVMA is now available.

Agvet businesses interested in participating in the efficacy contestability pilot should contact the APVMA’s efficacy assessment coordinator. An application is considered suitable if an efficacy and target crop/animal safety assessment is required and if the product type can be assessed by a listed pilot efficacy reviewer.

The pilot opened for submission of applications on 1 July 2016 and was due to close on 30 June 2017. Following requests from potential applicants the due date for submission of applications has been extended for 12 months. Submission of applications for inclusion in the pilot will now close on 30 June 2018.

Consultation

The APVMA will be consulting with a wide range of stakeholders over the life of this project. Any formal consultation undertaken for this project will be published on the APVMA consultation page.